OpenClaim

Icatibant Side Effects

The most commonly reported side effects of icatibant include hereditary angioedema, product dose omission issue, and weight decreased, based on 7,880 FDA adverse event reports from 2011 to 2025. 8.7% of reports found the drug to be ineffective.

Icatibant side effects

Percentages show how often each reaction appears relative to total reports for icatibant.

1
Hereditary Angioedema40.0%3,150
2
Drug Ineffective8.7%684
3
Product Dose Omission Issue7.7%603
4
Weight Decreased7.6%596
5
Weight Increased7.4%586
6
Product Use Issue5.7%448
7
Injection Site Pain5.4%425
8
Off Label Use5.0%397
9
Inappropriate Schedule Of Product Administration5.0%393
10
Headache4.9%389
11
Malaise4.6%359
12
Covid-194.4%345
13
Stress4.1%327
14
Nausea3.7%288
15
Pain3.6%285

These are voluntary reports and do not establish that icatibant caused these reactions.

Report severity

71.4%Serious5,629 reports
41.6%Hospitalizations3,275 reports
3.5%Fatal275 reports

Seriousness is determined by the reporter, not by OpenClaim.

Icatibant drug interactions

Other drugs that appear in adverse event reports alongside icatibant. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Lanadelumab-flyo21.9%1,722
2
Ecallantide5.3%419
3
Berotralstat-dihydrochloride1.6%125
4
Epinephrine0.7%56
5
Omalizumab0.4%35
6
Methylprednisolone0.4%29
7
Diphenhydramine0.4%28
8
Garadacimab-gxii0.3%25
9
Tranexamic-acid0.3%21
10
Amlodipine0.3%20
11
Prednisone0.2%19
12
Rituximab0.2%18
13
Dupilumab0.2%18
14
Ramipril0.2%17
15
Montelukast-sodium0.2%13

Taken alongside

1
Epinephrine18.8%1,481
2
Diphenhydramine8.6%678
3
Sodium-chloride8.3%652
4
Albuterol7.4%586
5
Acetaminophen7.4%581
6
Sterile6.8%534
7
Ergocalciferol6.4%502
8
Heparin6.3%498
9
Cetirizine-hydrochloride6.1%477
10
Ondansetron5.9%465
11
Levothyroxine-sodium5.6%443
12
Lanadelumab-flyo5.6%440
13
Fluticasone4.8%381
14
Montelukast-sodium4.3%342
15
Omeprazole4.2%331

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports icatibant side effects

64.3% of icatibant adverse event reports involve female patients and 19.0% involve male patients. The largest age group is adult at 80%. These figures reflect who reports side effects, not underlying risk.

Sex

Female64.3%
Male19.0%
Unknown16.7%

Age group

< 20.3%
2–111.1%
12–171.9%
18–6479.9%
65+16.9%

What is icatibant used for

Conditions and purposes for which patients were taking icatibant when the adverse event was reported.

Abdominal DistensionAbdominal Pain UpperAcquired C1 Inhibitor DeficiencyAcquired Immunodeficiency SyndromeAnaphylactic ReactionAngioedemaAnxietyArthritisAsthmaAutonomic NeuropathyAbdominal DiscomfortAbdominal DistensionAbdominal PainAcquired C1 Inhibitor DeficiencyAcquired Complement Deficiency Disease

Showing 15 of 183 indications

Icatibant brand names and reporting trend

Icatibant is sold under the brand name Firazyr.

Brand names

Firazyr9,595

Quarterly reports (20112025)

20122016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking icatibant with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.